Academic journal article Defense Counsel Journal

Genetically Modified Foods: Labeling Issues Are Driving the Regulators and Counsel

Academic journal article Defense Counsel Journal

Genetically Modified Foods: Labeling Issues Are Driving the Regulators and Counsel

Article excerpt

The FDA's present posture assumes GMF are OK unless proved otherwise, but that stance may not be good enough for a consumer-rights public

GENETICALLY modified foods are in the news. From the introduction of the FlavrSavr[TM] tomato in 1994 to insect-resistant corn in 2000, controversy has swirled around the genetic modification of food crops. A major concern has been safety--in particular, unsuspected allergic reactions in some people. In 1992, the U.S. Food and Drug Administration (FDA) adopted a policy on genetically modified foods; in September 2000, a federal district court rejected a challenge to the FDA's policy.


Genetic modification is a method of breeding plants. Prior to the advent of genetic modification, which also is known as bioengineering or genetic engineering, plant breeders developed new foods or introduced new traits into crops by what was essentially a trial-and-error method--cross breeding. This process resulted in the tangelo, which is a cross between a tangerine and a grapefruit; high-yield rice; and disease-resistant corn.

Genetic modification, on the other hand, permits scientists to change food crops by introducing a copy of a gene for a specific trait, for example, a gene that protects potatoes against insects and viruses. A gene can be copied from any organism--another plant, an animal, or a microbe--thereby providing plant breeders with a much broader source of potentially useful genes than would otherwise be available through conventional breeding methods.(1)

By definition, genetically modified foods contain genes or parts of genes from other organisms, whether plant, animal or microbe. Genes function by producing specific proteins, and certain proteins can cause an allergic reaction in some people. Thus, there is always the possibility that a new gene inserted into an otherwise nonallergenic food could cause that food to become allergenic.

This is a particular problem if the new gene is derived from foods that commonly cause allergic reactions, such as milk, eggs, fish, crustacea, mollusks, tree nuts, wheat and legumes (especially peanuts and soybeans). These foods account for some 90 percent of food-based allergic reactions.


In 1992, in response to questions from industry and the public, the FDA published its Statement of Policy: Foods Derived from New Plant Varieties (policy statement), which was intended to clarify the agency's legal and regulatory framework for the oversight of foods derived from new varieties of plants developed through both the "old" and "new" breeding techniques.(2) At bottom, the policy statement indicated the FDA's intention to regulate foods developed through genetic modification within the existing framework of the Federal Food, Drug, and Cosmetic Act (FFDCA), the statute's implementing regulations and current practice. That is, according to the policy statement, the regulatory status of a food would depend on the food's objective characteristics and its intended use, "irrespective of the method by which it is developed."

In adopting the policy statement, the FDA did not engage in a formal notice-and-comment process or prepare an environmental impact statement or environmental assessment. Between 1992, when the policy statement was issued, and September 2000, at least 36 genetically modified foods went on the market.(3)

The FFDCA authorizes the FDA to regulate food safety. The provisions pertinent here are Section 402(a)(1) of the act, 21 U.S.C. [sections] 342(a)(1), which applies to "adulterated" food, and Section 409, 21 U.S.C. [sections] 348, applicable to food additives.

Under Section 402(a)(1), a food is "deemed" adulterated and thus unlawful "[i]f it bears or contains any [added] poisonous or deleterious substance which may render it injurious to health," but a food is not deemed adulterated if it contains a naturally occurring substance in amounts that do not "ordinarily render it injurious to health. …

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